T2DM (Type 2 Diabetes Mellitus)VIDANCT06094491
Virtual Diabetes Group Visits Across Health Systems
A study testing Virtual Group Visit in people with T2DM (Type 2 Diabetes Mellitus) and Hypertension, run by University of Chicago at 2 sites in United States.
Trial summary
The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Hypertension, Heart Disease Chronic
- What is being tested?
- Virtual Group Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at a PARTICIPATING clinic (at least one visit in year prior to first GV)
- Type 2 diabetes
- ≥ 18 years old
- A1C>8% within 6 months prior to first GV (we will first recruit patients with A1C>9%, then if spaces still available A1C>8.5%, then if spaces still available A1C>8%)
- At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
- English or Spanish speaking
- PCP assented to recruiting patient
- Patient provides written consent
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Access Community Health Network
Chicago, Illinois, 60661
Advocate Health Care
Orland Park, Illinois, 60462
About this study
Official title: VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial
The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
Managing diabetes can be complex and burdensome; patients must modify their diet, take medications, check their blood sugar, and visit their healthcare providers regularly. Diabetes group visits (GVs)-virtual group education and diabetes support, including goal setting-create a unique setting where patients can connect with peers and receive medical care and support. GVs can improve glycemic control and decrease healthcare utilization. GVs can provide patients with comprehensive care for their multimorbid chronic condition.
Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. The investigators propose to build on an established program of diabetes GVs. This proposal aims to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region. Access Community Health Network (ACCESS) is one of the largest federally qualified health centers (FQHCs) in the United States with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically under-resourced and low-income patients each year. Advocate Health Care (ADVOCATE) is a large, integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites. The system provides care across more than 129 primary care clinics in Illinois serving over 117,000 patients. Both are community-based health systems serving low-income communities in Chicago and are network partners of the Chicago Chronic Conditions Engagement Network (C3EN).
No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems. The ability to train, implement, and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the obstacles and facilitators for implementation. This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial.
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Hypertension, Heart Disease Chronic, Stroke, Hyperlipidemias, Peripheral Vascular Diseases
- Being tested
- Virtual Group Visit
- Keywords
- virtual group visits
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Stroke, Hyperlipidemias, Peripheral Vascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Group VisitBehavioural
Group visits must have these core components: diabetes education, group social support and goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Group Visit Arm | Experimental | These subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff. Receives: Behavioral: Virtual Group Visit |
| Usual Care Arm | No intervention | These subjects will receive usual diabetes care at ACCESS or Advocate health centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
This is blood test that measures the percent of glucose and hemoglobin bound together.
Measured: 12 months
Secondary outcomes (3)
Systolic blood pressure
Systolic blood pressure measures the arterial pressure
Measured: 12 months
Body Mass Index
Measure of body fat based on height and weight
Measured: 12 months
Low density lipoproteins
a measure of cholesterol in the blood
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start3 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, ACCESS Community Health Network, Midwest Clinicians' Network, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Arshiya Baig, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094491
- Sponsor's protocol ID
- IRB23-0325
- Other IDs
- P50MD017349-04
- Acronym
- VIDA
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIDA: Virtual Diabetes Group Visits Across Health Systems: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06094491
- Acronym / sponsor ID
- VIDA / IRB23-0325
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Hypertension, Heart Disease Chronic, Stroke, Hyperlipidemias, Peripheral Vascular Diseases
- Keywords
- virtual group visits
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, ACCESS Community Health Network, Midwest Clinicians' Network, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to evaluate the effectiveness of a virtual diabetes group visits on patients with type 2 diabetes mellitus (T2DM).
Detailed description
Managing diabetes can be complex and burdensome; patients must modify their diet, take medications, check their blood sugar, and visit their healthcare providers regularly. Diabetes group visits (GVs)-virtual group education and diabetes support, including goal setting-create a unique setting where patients can connect with peers and receive medical care and support. GVs can improve glycemic control and decrease healthcare utilization. GVs can provide patients with comprehensive care for their multimorbid chronic condition.
Virtual GVs provide an opportunity to adapt to the current trends of telehealth and the ability to increase reach and scalability across multiple sites. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. The investigators propose to build on an established program of diabetes GVs. This proposal aims to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region. Access Community Health Network (ACCESS) is one of the largest federally qualified health centers (FQHCs) in the United States with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically under-resourced and low-income patients each year. Advocate Health Care (ADVOCATE) is a large, integrated private not-for-profit health system that includes 26 hospitals and more than 500 ambulatory sites. The system provides care across more than 129 primary care clinics in Illinois serving over 117,000 patients. Both are community-based health systems serving low-income communities in Chicago and are network partners of the Chicago Chronic Conditions Engagement Network (C3EN).
No studies have systematically implemented virtual diabetes GVs for adults with T2DM in the real-world primary care setting or across distinct health systems. The ability to train, implement, and evaluate virtual GVs across systems with different care models provides the opportunity to learn about adaptation and the obstacles and facilitators for implementation. This proposed study will compare virtual diabetes GVs to usual care using a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Type I hybrid effectiveness-implementation cluster randomized trial among adult patients with T2DM across 9 intervention sites and 9 control sites
| Arm | Type | Receives |
|---|---|---|
| Virtual Group Visit Arm | Experimental | Behavioral: Virtual Group VisitThese subjects will attend 6 monthly virtual group visits hosted by ACCESS or Advocate research staff. |
| Usual Care Arm | No intervention | –These subjects will receive usual diabetes care at ACCESS or Advocate health centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient at a PARTICIPATING clinic (at least one visit in year prior to first GV)
- Type 2 diabetes
- ≥ 18 years old
- A1C>8% within 6 months prior to first GV (we will first recruit patients with A1C>9%, then if spaces still available A1C>8.5%, then if spaces still available A1C>8%)
- At least one additional cardiovascular condition (hypertension, heart disease, stroke, hyperlipidemia, peripheral vascular disease, or BMI ≥ 30)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Group VisitGroup visits must have these core components: diabetes education, group social support and goal setting. | Behavioural | Virtual Group Visit Arm |
Primary outcome
A1c
Time frame: 12 months
This is blood test that measures the percent of glucose and hemoglobin bound together.
3 secondary outcomes
Systolic blood pressure
Time frame: 12 months
Body Mass Index
Time frame: 12 months
Low density lipoproteins
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshiya Baig, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Group Visit in people with T2DM (Type 2 Diabetes Mellitus) and Hypertension, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.